We want to examine the effect of the antihistamine Ebastine on abdominal pain and other symptoms associated with IBS and the quality of life. Through this research we would like to emphasize that this study primarily focuses on improvements of the…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoinst in this study is the effect of ebastine on abdominal pain
and global relief of symptoms in IBS patients
Secondary outcome
Secondary, we will assess the impact on the IBS stool consistency and frequency
and many other common complaints such as bloating, flatulence, urgency and
feeling of incomplete evacuation. Finally, we will determine the effect of the
treatment on the quality of life.
Background summary
It is estimated that in the Western world, 1 in 5 people suffer from irritable
bowel syndrome (IBS; synonyms: spastic colon and IBS). Typical complaints of
IBS are abdominal pain or discomfort and a changing defecation pattern. These
complaints occur without a clear organic cause. The treatment of IBS so far is
rather disappointing. Today the treatment of IBS consists of advice, fiber
preparations, agents that reduce the tone of the bowel or stimulate motility of
the intestine ("antispasmodics" and "prokinetics"), low-dose antidepressants
and painkillers. Recently, it was demonstrated that the gut of IBS patients
showed a slight increase in inflammation. This inflammation is too low to speak
of an inflammatory disease (such as Crohn's disease or ulcerative colitis) but
this inflammation could be the cause of the development of symptoms.
Inflammatory cells can secrete substances that may cause increased sensitivity
of the intestine, which occures in many IBS patients,. One of the substances
which can be secreted by inflammatory cells, is histamine. Therefore we now
investigate a drug that counteracts the effects of histamine. The drug
(Ebastine) is currently used in the treatment of allergic diseases.
Study objective
We want to examine the effect of the antihistamine Ebastine on abdominal pain
and other symptoms associated with IBS and the quality of life. Through this
research we would like to emphasize that this study primarily focuses on
improvements of the symptoms associated with IBS.
Study design
The studydesign is multicentric, double-blind, randomized and
placebo-controlled. It includes a two-week screening, followed by a treatment
period followed by a 2 week follow-up period. Patients will be randomized 1:1
for a 12 weeks of treatment with 20mg 1dd ebastine or placebo (Figure see
protocol). The patient has to fill out daily and weekly questionnaires about
their symptom relief and quality of life. These questionnaires will serve as
source documents in the study.
Intervention
12 weeks treatment with placebo or Ebastine
Study burden and risks
The risk for the subject is very small because the risk of side effects of
Ebastine is very rare (1 in 10 000). For the patient, the load of the study is
not that big. The patient must fill out questionnaires weekly and come to visit
the doctor for 5 times.
Herestraat 49
Leuven 3000
BE
Herestraat 49
Leuven 3000
BE
Listed location countries
Age
Inclusion criteria
1. Patients meet the ROME III criteria for IBS and is NOT diagnosed with the
constipation dominant subform of IBS (IBS-C), 2. No identifiable organic
explanation for the symptoms (including the execution of a test for lactose
intolerance, celiac disease and giardia test), 3. Age 18-65 years, 4. Signed
informed consent, 5. Symptoms during the two weeks of screening
Exclusion criteria
1. IBS constipation dominant, 2. Patient with history of:, Celiac disease,
Known milk allergy, giardiasis, inflammatory bowel disease, active intestinal
infection, chronic intestinal ischemia, chronic subobstruction,
pseudo-obstruction, dumping syndrome, pancreatic insufficiency, hepatic
impairment, renal function impairment, cardiovascular disease, extensive
gastrectomy and/or bowel resection, active malignant disease,
thyroiddysfunction, insulin dependent diabetes mellitus, psychiatric disorder,
any clinical condition in which the researcher does not allow to terminate the
study safely, 3. Pregnancy, breastfeeding, 4. Medication: Use of
anti-allergica, antidepressants, and antipsychotics, 5. Patient uses drugs that
reduce gastrointestinal motility and / or affect the visceral perception
(anticholinergics, antispasmodics, 5-HT4 agonists, cholinomimetics, loperamide,
laudanum, codeine, stimulant laxatives, macrogol, paraffin oil,
anti-inflammatory agents) OR mediaction knwon to prolong QTc-interval
(antifungals (ketoconazol) and macrolides (erytromycien, claritromycine))., 6.
Complaints arise after abdominal surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-001199-39-NL |
| ClinicalTrials.gov | NCT01908465 |
| CCMO | NL45773.018.13 |